The following data is part of a premarket notification filed by Us Vascular, Llc with the FDA for Vasculab Vl4000 Photoplethysmograph With Pulse Volume Recording.
| Device ID | K131860 |
| 510k Number | K131860 |
| Device Name: | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING |
| Classification | Transducer, Ultrasonic |
| Applicant | US VASCULAR, LLC 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith US VASCULAR, LLC 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861446000401 | K131860 | 000 |